🏥 Medical Devices Class I - Dangerous
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
All Recalls
95,025 total recalls in our database
🏥 Medical Devices Class I - Dangerous
An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA when compared to a previous lot of product. The observed elevated bias between these two lots is largely due to samples with higher levels of antibodies. With the cut-off for the assay being 15 U/mL, the clinical classifications for most samples would remain unchanged.
🏥 Medical Devices Class I - Dangerous
Potentially counterfeit products in/and counterfeit packaging were imported to the U.S.
🏥 Medical Devices Class I - Dangerous
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
🏥 Medical Devices Class I - Dangerous
Cases of Portex¿ Lumbar Puncture Tray Child, SKU #4826PL-20 had been mislabeled with invalid information. The product was correct, but the inner trays were labeled as 4824PL-20 instead of 4826PL-20.
ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
ICU Medical
🏥 Medical Devices Class I - Dangerous
Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate monitoring data, unit shutdown, and/or loss of display of a secondary parameter.
🏥 Medical Devices Class I - Dangerous
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Radiometer Medical ApS
🏥 Medical Devices Class I - Dangerous
Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.
CapsoCAM Plus, UDI: 00867770000209
Capso Vision
🏥 Medical Devices Class I - Dangerous
Capsule Endoscopy System: a defect present in the capsule window may be stressed through the production process and in the final package, which could cause the housing of the capsule to crack and leak when ingested. Fluid from the patient could leak in to the capsule, which may damage components inside the capsule and the patient data may not be retrieved; the patient may need to repeat the exam.
Prismaflex System, Prismaflex Control Unit
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
Prepac 4-drawer chests
Prepac Manufacturing Ltd., of Canada
🏠 Consumer Products Class I - Dangerous
The recalled chests are unstable and can tip over if not anchored to the wall, posing serious tip-over and entrapment hazards that can result in death or injuries to children.
Power adapters sold with Epson scanners
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The power adapters can overheat, melt and catch fire, posing burn and fire hazards.
Flash Receivers
Bellman & Symfon AB, of Sweden
🏠 Consumer Products Class II - Moderate
The back-up battery can fail to fully charge resulting in the receiver not working as intended and failing to flash to alert hearing-impaired persons to an emergency.
Essential Trading Post Wintergreen and Birch Essential Oils
Essential Trading Post, of New Bedford, Mass.
🏠 Consumer Products Class II - Moderate
The products contain the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products are not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
Rechargeable battery packs
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The rechargeable battery packs can short circuit, causing them to overheat, posing a burn hazard to consumers.
Children's Neck Pillows
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
Paint on the zippers and zipper pulls contains levels of lead that exceed the federal lead paint ban. Lead is toxic if ingested by young children and can cause adverse health effects.
🍎 Food Class I - Dangerous
Product contains undeclared milk.
🍎 Food Class I - Dangerous
Product is potentially contaminated with Listeria monocytogenes.
💊 Drugs Class I - Dangerous
Defective Delivery System: Out of specification for mechanical peel and shear.
Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.